Method and apparatus for anchoring laparoscopic instruments

ABSTRACT

A balloon anchor provides for the anchoring of a surgical instrument, such as conventional trocar sheath, within a puncture opening formed by a trocar. When used on a trocar sheath, the anchor is secured to the smooth outer surface of the sheath for extension through the puncture opening as the trocar within the sheath forms the opening. Adhesive or mechanical means are provided to secure the balloon the instrument. No modification to the structure of the instrument is required. Once in place within the opening, the balloon is inflated to the interior of the tissue to anchor the instrument in place. Certain embodiments also provide for inflation of the balloon within and/or to the exterior of the opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of and claims the benefit ofpriority to U.S. patent application Ser. No. 08/447,794 filed on May 23,1995 now U.S. Pat. No. 6,524,283, which is a Divisional Application ofand claims the benefit of priority to application Ser. No. 08/320,042now U.S. Pat. No. 5,697,946 filed on Oct. 7, 1994, the entire contentsof which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to an improved anchor for securinglaparoscopic instruments within puncture opening during surgery. In itsmore specific aspects, the invention is concerned with a balloon anchoradapted to be secured to the outside surface of virtually anylaparoscopic instrument, without the necessity of modifying thestructure of the instrument.

Laparoscopic surgery provides a minimally invasive approach to a widevariety of surgical procedures in, for example, the abdominal andthoracic cavities. In a minimally invasive approach, small incisions aremade to provide access for instruments needed to perform surgery. Theinstruments, such as trocars, endoscopes, clip appliers, cautery devicesand other tools, are commonly inserted through these small incisionsusing cannulas which are adapted to provide a pressure seal when usingpneumoperitoneum. It is desirable to secure or anchor these cannulasinto position in the incision to allow easy insertion and withdrawal ofinstruments through the cannula without corresponding movement of thecannula. Likewise, it is sometimes desirable to secure or anchor aninstrument itself in an incision and prevent unwanted distal or proximalmovement of the instrument.

Prior anchors for laparoscopic instruments have employed threadedsleeves adapted to be secured to the instruments and screwed into alaparoscopic puncture opening to secure the instrument in place. Ananchor of this type is found in U.S. Patent No. 5,217,441. Such anchorsrequire a specific size for each size of instrument, since the sleevemust be of a configuration complemental to that of the instrument. Thescrew threads also must be twisted into place and are relativelytraumatic.

The prior art also teaches adhesive anchors, sometimes called“grippers,” for securing laparoscopic instruments in place withinpuncture openings. Such anchors employ a tubular boss configured tosnugly engage the instrument and a flexible disk carried by the boss foradhesion to the outside surface of the punctured tissue. The boss mustbe specifically configured to match the configuration of the instrumentbeing anchored. Blood emitting from the puncture opening often intrudesbetween the disk and the tissue so as to destroy the integrity of theanchor during surgery.

The prior art also teaches the provision of specially constructedlaparoscopic cannula provided with inflatable balloons to anchor thecannula in place within a puncture opening. A cannula of this type maybe seen in U.S. Pat. No. 5,002,557. Such cannula are expensive tofabricate and must be especially configured to match the instrument withwhich they are used.

It is also old in the art to anchor drainage catheters with balloonsincorporated into the catheter. One well-known catheter of this typeused for urinary drainage is the “Foley” catheter. In such catheters,the balloon and the conduit provided for its inflation is integrallymolded into the catheter.

SUMMARY OF THE INVENTION

The present invention is an improvement over the prior art in that itprovides a universal balloon anchor which may be secured to the outsideof a laparoscopic instrument and inflated to anchor the instrument inplace within a puncture opening. The balloon is configured so as to havea low profile generally contiguous with the outside surface of theinstrument to facilitate its low insertion force placement and removal,without significant trauma to the tissue defining a small laparoscopicopening.

In its broadest aspects, the anchoring system of the invention providesa low profile balloon adapted to be engaged with the outside surface ofa laparoscopic instrument. In the preferred embodiments, the balloon isadhesively secured to the instrument. Certain embodiments also employmechanical structure to constrain the balloon and hold it in place.Conduit means for inflating the balloon is also secured externally ofthe instrument being anchored.

In the method of the invention, the balloon is secured to the outersurface of an instrument to be anchored with the balloon in a deflatedlow profile configuration essentially contiguous with the outer surfaceof the instrument. The instrument is then extended through the punctureopening within which it is to be anchored so as to dispose at least aportion of the balloon to the inside of the opening. The balloon is theninflated to anchor the instrument.

A principal object of the invention is to provide a universal anchorwhich may be secured to virtually any instrument used for laparoscopicsurgery to anchor the instrument within a puncture opening.

Another and related object is to provide such an anchor which isinexpensive and may be used with a minimum of trauma to the puncturedtissue.

Yet another object of the invention is to provide such an anchor whichcan accommodate puncture openings formed in tissues of different wallthicknesses.

Still another object of the invention is to provide such an anchor whichmay form a seal around the puncture.

Still another and more specific object of the invention is to providesuch an anchor which may lock the instrument against movement eitherinto or out of a puncture opening.

A further object of the invention is to provide such an anchor which maybe used for both gasless- and gas-(insufflation) type laparoscopicsurgery.

Another object of the invention is to provide such an anchor which maybe located anywhere along the length of a laparoscopic instrument andwhich can be used in multiples, if desired.

Yet a further object of the invention is to provide such an anchor whichis ideally suited for one-time use and does not have such bulk as tocreate undue disposal problems.

The foregoing and other objects will become more apparent when viewed inlight of the following detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan of a first embodiment of the anchor, employing aballoon provided with an adhesive backing wherein a shielding strip istemporarily disposed over the backing;

FIG. 2 is an elevational view of the anchor shown in FIG. 1;

FIG. 3 is a cross-sectional view of the anchor shown in FIG. 1, taken onthe plane designated by line 3—3;

FIG. 4 is an elevational view of the FIG. 1 anchor in place on a trocarsheath, with the balloon of the anchor in a deflated condition and atrocar extended through the sheath in the process of forming a punctureopening in a tissue layer;

FIG. 5 is an elevational view similar to that of FIG. 4, showing thesheath fully extended through the puncture opening, with the ballooninflated and the trocar removed from the sheath;

FIG. 6 is a plan view of a second embodiment of the anchor, employing aballoon of an elongate generally hourglass-shaped configuration providedwith an adhesive backing wherein a shielding strip is temporarilydisposed over the backing;

FIG. 7 is an elevational view of the anchor shown in FIG. 6;

FIG. 8 is an cross-sectional view of the anchor shown in FIG. 6, takenon the plane designated by line 8—8;

FIG. 9 is an elevational view of the FIG. 6 anchor in place on a trocarsheath with the balloon of the anchor in a deflated condition and atrocar extended through the sheath in the process of forming a punctureopening in a tissue layer;

FIG. 10 is an elevational view similar to FIG. 9, showing the sheathfully extended through the puncture opening, with the balloon inflatedand the trocar removed from the sheath;

FIG. 11 is a plan view of a third embodiment of the anchor, employing aballoon having a securing patch disposed thereover wherein the patch isprovided with an adhesive backing and a shielding strip is temporarilydisposed over the backing;

FIG. 12 is an elevational view of the anchor shown in FIG. 11;

FIG. 13 is a cross-sectional view of the anchor shown in FIG. 11, takenon the plane designated by line 13—13;

FIG. 14 is an elevational view of the FIG. 11 anchor in place on atrocar sheath, with the balloon of the anchor in a deflated conditionand a trocar extended through the sheath in the process of forming apuncture opening in a tissue layer;

FIG. 15 is an elevational view similar to that of FIG. 14, showing thesheath fully extended through the puncture opening, with the ballooninflated and the trocar removed from the sheath;

FIG. 16 is a plan view of a fourth embodiment of the anchor employing aballoon, wherein the balloon has two separately inflatable chambers andan adhesive backing with a shielding strip temporarily disposed over thebacking;

FIG. 17 is an elevational view of the anchor shown in FIG. 16;

FIG. 18 is a cross-sectional view of the anchor shown in FIG. 16, takenon the plane designated by line 18—18;

FIG. 19 is an elevational view of the FIG. 16 anchor in place on atrocar sheath with the balloon of the anchor in a deflated condition andthe trocar extended through the sheath in the process of forming apuncture opening in a tissue layer;

FIG. 20 is an elevational view similar to that of FIG. 19, showing thesheath fully extended through the puncture opening, with both chambersof the balloon inflated and the trocar removed from the sheath;

FIG. 21 is a perspective view of a fifth embodiment of the anchoremploying a balloon with an adhesive backing, wherein the balloon iselongate and extends across the backing;

FIG. 22 is a perspective view of the anchor shown in FIG. 21 adhesivelysecured to a trocar sheath, with the balloon in a deflated conditionfolded against the sheath;

FIG. 23 is a perspective view similar to that of FIG. 22, showing theballoon inflated and extending transversely to either side of thesheath;

FIG. 24 is an elevational view of a sixth embodiment of the anchor inplace on a trocar sheath, with the balloon of the anchor in a deflatedcondition and a trocar extended through the sheath in the process offorming a puncture opening in a tissue layer;

FIG. 25 is an elevational view similar to that of FIG. 24, showing thesheath fully extended through the puncture opening, with the ballooninflated and the trocar removed from the sheath;

FIG. 26 is a cross-sectional view taken on the plane designated by line26—26 of FIG. 24;

FIG. 27 is a cross-sectional view taken on the plane designated by line27—27 of FIG. 25;

FIG. 28 is an elevational view of a seventh embodiment of the anchor inplace on a trocar sheath, with the balloon of the anchor in a deflatedcondition and a trocar extended through the sheath in the process offorming a puncture opening in a tissue layer;

FIG. 29 is an elevational view similar to that of FIG. 28, showing thesheath fully extended through the puncture opening, with the ballooninflated and the trocar removed from the sheath;

FIG. 30 is a cross-sectional view taken on the plane designated by line30—30 of FIG. 28;

FIG. 31 is a cross-sectional view taken on the plane designated by line31—31 of FIG. 29;

FIG. 32 is an elevational view of an eighth embodiment of the anchor inplace on a trocar sheath with the balloon of the anchor in a deflatedcondition and a trocar extended through the sheath in the process offorming a puncture opening in a tissue layer;

FIG. 33 is an elevational view similar to that of FIG. 32, showing thesheath fully extended through the puncture opening, with the balloons ofthe anchor inflated and the trocar removed from the sheath;

FIG. 34 is a cross-sectional view taken on the plane designated by line34—34 of FIG. 33;

FIG. 35 is a plan view of a flat balloon adapted to be wrapped around atrocar sheath to provide a generally angular balloon in a ninthembodiment of the anchor;

FIG. 36 is an elevational view of the ninth embodiment of the anchor inplace on a trocar sheath, with the balloons of the anchor in a deflatedcondition and a trocar extending through the sheath in the process offorming a puncture opening in a tissue layer;

FIG. 37 is an elevational view similar to that of FIG. 36, showing thesheath fully extended through the puncture opening, with the balloonsinflated and the trocar removed from the sheath;

FIG. 38 is a cross-sectional view taken on the plane designated by line38—38 of the FIG. 36;

FIG. 39 is a cross-sectional view taken on the plane designated by line39—39 of FIG. 37;

FIG. 40 is a plan view of a tenth embodiment of the anchor employing adistal balloon corresponding generally to that of the first embodimentand a proximal balloon connected to the distal balloon by a web;

FIG. 41 is a plan view of the tenth embodiment anchor wherein theproximal balloon has been folded over and wrapped around the air passageleading to the distal balloon;

FIG. 42 is an elevational view of the tenth embodiment anchor in placeon a trocar sheath, with the balloons of the anchor in a deflatedcondition and a trocar extending through the sheath in the process offorming a puncture opening in a tissue layer;

FIG. 43 is an elevational view similar to that of FIG. 42, showing thesheath fully extended through the puncture opening, with the balloonsinflated and the trocar removed from the sheath; and,

FIG. 44 is a cross-sectional view taken on the plane designated by line44—44 of FIG. 43.

DESCRIPTION OF THE PREFERRED EMBODIMENTS First Embodiment

As shown in FIGS. 1–3, this embodiment comprises an elastomeric balloon10 having a first film layer 11 of elastic or semi-elastic material, anda second film layer 12 of elastic, semi-elastic or inelastic material.Second film layer 12 is ideally very flexible so that it can easilyconfirm to the outside surface of an instrument such as a trocar sheath.Preferably, first film layer 11 and second film layer 12 are made ofmaterial suitable for medical applications having a good strength tothickness ratio. Thinner materials facilitate lower deflated profilesand thus lower incision insertion forces. First film layer 11 can bemade of urethane or other appropriate film. A semi-elastic PS-8010polyurethane film, referred to as PS-8010, manufactured by DeerfieldUrethane of Deerfield, Mass. is suitable. Second film layer 12 ispreferably a flexible inelastic material, such as polyester. A suitablematerial is Rexham 705517 manufactured by Rexham Industrial, Inc. ofMatthews, N.C. Alternatively, first and second film layers 11, 12 can bemade of the same elastic or semi-elastic material if desired. A contactadhesive 14 is adhered to the undersurface of second layer 12 andcovered by a removable paper or plastic shielding strip 16. Contactadhesive 14 and corresponding shielding strip 16 are cut-away atportions 13 to facilitate unrestrained expansion of the balloon uponinflation. An inflation tube 18 is integrally formed by bonding firstand second film layers 11, 12 together. A check valve or stop cock 20 issecured to the proximal end of the tube 18 for purposes of introducinginflation fluid (liquid or gas) into the tube 18.

In the embodiment illustrated, the balloon 10 is formed by peripherallybonding first layer 11 and second layer 12 together thereby creating asealed inflatable chamber 9 therebetween. An alternative constructionfor the balloon would be to fabricate the balloon as a closedelastomeric envelope with contact adhesive applied directly one side ofthe envelope. With such a construction, a removable paper or plasticshielding strip would also be provided over the adhesive. In use, theballoon of such a construction would be adhered directly to aninstrument with the contact adhesive. The surface of the instrumentwould serve as the inelastic backing restraining the balloon fromelongation upon inflation.

FIG. 4 illustrates the first embodiment balloon attached to the smoothouter surface of an instrument, in this case a conventional trocarsheath 22. As there shown, the shielding strip 16 has been removed fromthe adhesive 14 and the second film layer 12 is adhered to the sheath bythe adhesive. In the deflated condition shown in FIG. 4, the balloon 10and tube 18 have a low profile essentially contiguous with the outsidesurface of the sheath 22.

FIG. 4 also shows a sharp tipped trocar 24 extending through the sheath22 and into piercing engagement with a layer of living tissue 26 such asan abdominal wall. The sheath 22 is telescopically received on thetrocar 24 and moves with the trocar through the tissue 26.

FIG. 5 shows the sheath 22 extended fully through a puncture opening 28which has been formed by the trocar 24, with the trocar removed from thesheath. As shown in FIG. 5, the balloon 12 has been inflated to theinterior of the tissue to anchor the sheath distally against removalfrom the puncture. With the sheath so anchored, other instruments can bepassed therethrough for diagnostic or surgical purposes and withdrawnfrom the sheath without unwanted proximal movement of the sheath. Uponcompletion of the procedure, the balloon 12 is deflated to return to thecondition shown in FIG. 4 and the sheath may be removed from theincision with a minimum of trauma.

Second Embodiment

This embodiment is illustrated in FIGS. 6–10 and is similar to the firstembodiment, with the exception that the balloon 10 a is of an elongatehourglass-shaped configuration. Parts of the second embodimentcorresponding to those of the first embodiment are designated by likenumerals followed by the letter a, as follows: elastic balloon 10 a;first layer 11 a; second layer 12 a; chamber 9 a; adhesive cut-awayportions 13 a; contact adhesive 14 a; shielding strip 16 a; inflationtube 18 a; and check valve or stop cock 20 a.

The second embodiment balloon is applied and used in the same way asthat of the first embodiment. As seen in FIG. 9, the balloon is adheredto the outside surface of a trocar sheath 22 so as to extendlongitudinally of the sheath. The hourglass shape of the balloon 10 aprovides distal and proximal portions 30 and 32, respectively. Uponextension of the sheath 22 through the tissue as shown in FIG. 10, theseportions are disposed to either side of the tissue 26 to anchor thesheath 22 against movement distally into or proximally out of theopening 28 through which the sheath extends. The necked-down portion ofthe balloon 10 a, designated 34, does not significantly expand uponinflation of the portions 30 and 32. Constraint of the portion 34 isprovided both by its reduced dimension, as compared to the portions 30and 32, and its adherence to the second film layer 12 a.

Like the first embodiment balloon, when in the deflated condition theballoon 10 a assumes a low profile configuration essentially contiguouswith the outside surface of the sheath 12. This minimizes trauma to thetissue both during insertion and removal of the sheath.

Third Embodiment

As shown in FIGS. 11–15, the third embodiment is similar to that of thefirst embodiment, with the exception that the balloon, designated 10 b,is a closed elastomeric envelope having top and bottom surfaces; and thebacking strip is a patch 36 adhered to and extending over the balloon.The patch 36 is provided with contact adhesive 38 to either side of theballoon 10 b. A removable paper or plastic shielding strip 16 b extendsacross the balloon 10 b and over the adhesive 38. Inflation tube 18 bfor the third embodiment is contiguous with the balloon 10 b and alsoadhered beneath the patch 36. Contact adhesive 38 on the patch 36 isdisposed to either side of the tube 18 b and covered by the removableshielding strip 16 b. A check valve or stop cock 20 b is secured in theproximal end of the inflation tube 18 b.

In use, the shielding strip 16 b is removed from the adhesive 38 and theballoon assembly is secured directly to the outside surface of theinstrument with which it is used by the patch 36. FIG. 14 shows theballoon so applied to a trocar sheath 22 having a trocar 24 extendedtherethrough. The adhesive 38 to either side of the balloon lob andinflation tube 18 b adheres directly to the smooth outside surface ofthe trocar sheath 22. A perforated tear line 40 is formed in the patch36 over the balloon 10 b.

Once secured in place as shown in FIG. 14, the third embodiment balloon10 b is extended through the tissue 26 in the same manner as the firstembodiment balloon. After being extended fully through the tissue asshown in FIG. 40, the balloon is inflated to the inside of the tissue.Such inflation functions to tear the patch 36 along the frangible tearline 40. Upon completion of the surgical procedure or as otherwisedesired, the balloon may be deflated to return to its condition closelycontiguous to the sheath so that the sheath may be removed with aminimum of trauma.

The third embodiment sheath shown in FIGS. 11–15 is provided with a thinspacer string 42 between the inner and outer sides of the balloon 10 b.Ideally, this string extends over the full length of the balloon 10 band inflation tube 18 b so as to prevent the sides of the balloon andtube from fully closing against one another when the balloon is in thedeflated condition. The space provided by the string provides a fluidpassage and facilitates inflation of the balloon with a minimum ofpressure. Although the string is only shown in the third embodiment, itshould be understood that it might be applied to any of the embodimentsdiscussed herein.

Fourth Embodiment

As shown in FIGS. 16–20, the fourth embodiment corresponds to the firstembodiment, with the addition that it is provided with a second balloon44 of an elongate-divergent configuration. The balloon 44, as may beseen in FIG. 16, diverges from the distal balloon, designated 10 c. Theballoons 10 c and 44 provide separate inflation chambers. A separateinflation tube 46 having a check valve or stop cock 48 is provided forinflation of the balloon 44. The elements of the fourth embodimentcorresponding to those of the first embodiment are designated by likenumerals, followed by the letter c, as follows: balloon 10 c; first filmlayer 12 c; second film layer 12 c; adhesive cut-away portions 13 c;contact adhesive 14 c; shielding strip 16 c; inflation tube 18 c; and,check valve or stop cock 20 c.

The fourth embodiment anchor is applied to an instrument and surgicallyinserted in the same manner as the first embodiment anchor. Such anapplication may be seen in FIG. 19 wherein the fourth embodiment anchoris shown attached to the smooth outside surface of the trocar sheath 22having a sharp tipped trocar 24 extended therethrough into piercingengagement with a layer of living tissue 26. Once extended through thetissue as shown in FIG. 20 a, the balloon 10 c is first inflated to theinterior of the tissue to anchor the sheath against removal in theproximal direction. The second balloon 44 is then inflated to anchor thesheath against movement interiorally of the tissue in the distaldirection relative to the user. The elongate tapered configuration ofthe balloon 44 accommodates tissue of virtually any thickness and canalso serve to form a seal between the interior of the puncture 28 andthe sheath 22. Upon completion of the surgical procedure, both balloonsare deflated and the sheath is removed, with a minimum of trauma.

Fifth Embodiment

The balloon of this embodiment, as shown in FIGS. 21–23, is of agenerally T-shaped configuration and fabricated of superimposed sheetsof flexible inelastic film. The commercially available film known asRexham 705517 has been found suitable.

FIG. 21 shows the fifth embodiment anchor in deflated condition as itwould be supplied for use with any desired surgical instrument. Theanchor comprises a balloon 52 fabricated of superimposed peripherallyconnected sheets of elastic, semi-elastic or inelastic flexible film.Preferably, semi-elastic urethane material is used. The balloon has anelongate transverse section 56 and a longitudinally extending section58. An inflation tube 60 having a check valve or stop cock 62 is securedin fluid communication with the section 58. A contact adhesive layer issecured to and extends over the section 58. A removable shielding strip66 is disposed over the adhesive 64. As shown, the adhesive 64 isadhered directly to the balloon 52.

The fifth embodiment anchor is adhered to the outside surface of aninstrument and used in essentially the same manner as the firstembodiment anchor. FIG. 22 shows the anchor secured to a trocar sheath22. As there shown, the shielding strip 66 has been removed from theadhesive and the section 58 has been adhered longitudinally of thesheath with the adhesive 64. While FIG. 22 shows the ends of thetransverse balloon section 56 folded over the section 58, it should beunderstood that these ends are not adhered to the sheath. The foldedover condition is simply for purposes of reducing the profile of theballoon during insertion.

FIG. 23 shows the balloon as it would appear after inserted into placethrough a puncture and inflated. Such insertion would be carried out inessentially the same manner shown in FIGS. 4 and 5. Once in place withthe transverse section 56 to the interior of the pierced tissue,inflation of the anchor functions to expand the transverse sectiontransversely of the trocar sheath 22, thus securely anchoring the sheathagainst removal from the puncture opening. Upon completion of thesurgical procedure, the balloon is deflated and may collapse against thesheath upon removal, with a minimum of trauma.

Sixth Embodiment

The sixth embodiment anchor is of an elongate toroidal configuration andadapted to be slipped over and around a surgical instrument, withoutneed for an adhesive. As shown in FIGS. 24–27, this embodimentcomprises: an elongate toroidal elastic balloon 68; spaced proximal anddistal rings 70 and 72, respectively, disposed within the balloon 68; anintermediate ring 74 disposed around the balloon between the proximaland distal rings; and, an inflation tube 76 communicating with theinterior of the balloon through a flange 78 on the ring 70. As shown,the balloon 68 is fabricated of a sleeve folded over upon itself withone end of the sleeve tied to the ring 72 by a cord 80 and the other endof the sleeve tied to the outside of the flange 78 by a cord 82.

In use, the sixth embodiment anchor is simply slipped over theinstrument to which it is applied. In the exemplary embodimentillustrated, the instrument comprises a trocar sheath 22. As shown inFIG. 24, the balloon is deflated and a sharp tipped trocar 24 extendsthrough the sheath 22 into piercing engagement with a layer of livingtissue 26. Once fully extended through the tissue, the balloon 68 isinflated as shown in FIG. 25 to expand to either side of the tissue. Asso expanded, the balloon forms donut-shaped barriers to either side ofthe tissue. Expansion of the balloon within the thickness of the tissueis prevented by the ring 74. The space between the rings 72 and 70permits the interior wall of the balloon to expand into grippingengagement with the sheath, as shown in FIG. 27. Thus, the sheath isanchored against movement into or out of the pierced tissue. Uponcompletion of the surgical procedure, the balloon is deflated andreturns to the condition shown in FIG. 26, thus permitting removal ofthe anchor with a minimum of trauma.

To maintain the orientation of the rings in the sixth embodiment, one ormore thin ribs may be provided between the proximal and distal rings 70and 72. These ribs (not illustrated) are so proportioned and spaced soas not to interfere with inward expansion of the balloon into grippingengagement with the sheath, as shown in FIG. 27. The outer intermediatering 74 may be adhered to the outside surface of the balloon 68 toprevent its displacement along the balloon.

Seventh Embodiment

The seventh embodiment anchor is similar to that of the sixth embodimentin that it employs an elongate toroidal balloon adapted to be receivedaround the instrument to be anchored. In the case of the seventhembodiment, however, the balloon is preferably fabricated so that thedistal portion of the balloon is elastomeric and the proximal portion isinelastic. FIG. 30 shows such a construction wherein an innerelastomeric sleeve 84 is folded upon itself to provide a distal balloonsection 86. An inelastic sleeve 88 is extended over the sleeve 84. Theinelastic sleeve 84 is circumferentially welded to the folded over endof the inner sleeve 84 at a weld line 90. From the weld line to thedistal end of the inelastic sleeve a perforated tear line 92 is providedto permit the sleeve to break upon expansion of the distal balloonsection 86. The proximal end of the outer inelastic sleeve 88 is foldedupon itself and circumferentially sealed to a flange member 94 by a tie.An inflation tube 96 extends through the flange member 94 into fluidcommunication with the interior of the balloon formed by the sleeves 84and 88.

In use, the seventh embodiment anchor is slipped around the instrumentto be anchored. As shown in FIG. 28, the instrument comprises a trocarsheath 22 having a sharp tipped trocar 24 extending therethrough in theprocess of piercing an opening in a layer of living tissue 26. Thetrocar is pushed fully through the tissue, together with the anchor.Once in place, as shown in FIG. 29, the trocar is removed and theballoon is inflated. Inflation functions to form toroidal balloonsections to either side of the tissue and to interiorally expand theballoon into gripping engagement with the sheath. Thus, the sheath isanchored against movement into or out of the tissue.

It will be appreciated that upon expansion of the distal balloon section86 the inelastic sleeve tears along the tear line 92. That portion ofthe sleeve 88 within the tissue remains intact and functions toconstrain the balloon. The proximal end of the balloon, designated 98,expands to a toroidal configuration by unfolding the folded overportions of the sleeve 88 (see FIG. 30). Upon completion of the surgicalprocedure, the balloon is deflated, thus permitting the anchor to beremoved with a minimum of trauma.

Eighth Embodiment

This embodiment is illustrated in FIGS. 32–34 and corresponds to thefirst embodiment, with the addition that it is provided with a toroidalballoon assembly 100 adapted to be slidably received around the balloon10 and its air passage 18. Elements of the eighth embodimentcorresponding to those of the first embodiment are designated by likenumerals. The purpose of the torodial balloon assembly 100 is to providean anchor “ring” which can be freely moved along a trocar sheath orother instrument to which the balloon 10 is adhered to provide askin-side anchor which may be adjusted to accommodate the thickness ofthe tissue (e.g., abdominal wall) through which the sheath is extended.Initially, the balloon assembly is in a deflated condition and freelymovable along the sheath. Upon being adjusted to the desired position(see FIG. 33), the assembly is inflated, thus causing its inner diameterto decrease into secure gripping engagement with the sheath.

Ideally, the balloon assembly 100 is fabricated with an elastic orsemi-elastic inner film layer 102 and an elastic or semi-elastic outerfilm layer 104 which are peripherally RF welded together. The materialsfor these layers may be the same as those suggested for the balloon ofthe first embodiment. A check valve or stop cock 20 is sealingly securedin the open end of the balloon assembly 100.

The inner construction of the toroidal balloon assembly 100 isillustrated in FIG. 34. As there seen, the assembly is elongate andwrapped upon itself to form a toroidal configuration. The proximal anddistal ends of the elongate balloon are adhered or welded together atarea 106. The trocar sheath 22 is shown slidably received within thetoroid provided by the assembly.

In use of the eighth embodiment, the balloon 10 would be secured to thesheath in a manner identical to that described with respect to the firstembodiment. The toroidal balloon assembly 100 would then be slid overthe sheath in a deflated condition. Then the sheath would be passedthrough the tissue 26 and anchored against removal by inflation of theballoon 10, as shown in FIG. 29. The deflated toroidal assembly 100would then be adjusted along the length of the sheath to engage theoutside of the tissue and then inflated, as shown in FIG. 33. The latterinflation functions to expand the assembly 100 into gripping engagementwith the sheath and anchor the sheath against movement distally relativeto the tissue.

Ninth Embodiment

This embodiment is shown in FIGS. 35–39 and is similar to the eighthembodiment in that it is used with the distal balloon 10 of the firstembodiment and provides a skin-side anchor. It differs from the eighthembodiment only in the construction of the skin-side anchor assembly,designated 108. Elements of the ninth embodiment corresponding to thoseof the first embodiment are designated by like numerals.

The anchor assembly 108 is similar to the assembly 100 in that it isfabricated of an elastic or semi-elastic inner film layer 110 and aninelastic or semi-elastic outer film layer 112 peripherally RF weldedtogether to provide a balloon. In the case of the assembly 108, however,a weld line 114 is formed to extend across the assembly intermediate itslength so that the balloon only extends over approximately one-half ofthe length of the assembly (see FIG. 35). Also, in the case of the ninthembodiment, the distal and proximal ends of the assembly are not weldedtogether, but rather are provided with contact adhesive 14 whereby theymay be selectively secured together after being wrapped around aninstrument. A check valve or stock cock 20 is sealingly received in theopen end of the balloon provided by the assembly 108.

FIGS. 38 and 39 show how the assembly 108 is placed around the trocarsheath 22. In FIG. 38, the assembly is being wrapped around the sheath.In FIG. 39, the distal and proximal ends of the assembly have beensecured together by the adhesive 14 and the balloon has been inflated toexpand the assembly into gripping engagement with the sheath.

In use, the ninth embodiment anchor is passed through a tissue layer inthe same manner as the first embodiment anchor and the distal balloon 10is then inflated, as seen in FIG. 37. Then the assembly 108 is slidalong the sheath 22 into engagement with the outside surface of thetissue. Once so engaged, the assembly is inflated to securely engage theassembly with the outside surface of the sheath and anchor the sheathagainst distal movement relative to the tissue.

FIG. 36 shows the assembly 108 in place around the sheath prior toextension of the sheath through the tissue layer 26. As an alternative,the assembly could be wrapped around the sheath after it has beenextended through the tissue. Such a procedure is possible because theassembly is capable of being wrapped around the sheath after it is inplace within a layer of body tissue.

Tenth Embodiment

This embodiment is shown in FIGS. 40–44 and also incorporates the distalballoon of the first embodiment. In the case of the tenth embodiment,however, a skin-side anchor assembly 116 is connected in transverserelationship to the inflation tube 18 by a flexible web 118. Elements ofthe tenth embodiment corresponding to those of the first embodiment aredesignated by like numerals.

The assembly 116 and web 118 are fabricated from continuations of thefilm layers forming the balloon 10 and the tube 18. These layers areperipherally welded together at a weld line 120 extending around theassembly 116. One end of the assembly 116 is open and sealingly receivesa check valve or stock cock 20. An aperture 122 proportioned for receiptover the distal end of the valve 20 is formed in the end of the assembly116 opposite that which receives the valve.

To prepare the tenth embodiment for use, the web 118 is folded over thetube 18 to dispose the first elastic film layer 11 of the assembly inopposition to the tube 18. Then the assembly is wrapped around theinflation tube 118 to engage the aperture 122 over the distal end of thevalve 20, as shown in FIG. 41. With the assembly 116 so prepared, thegenerally toroidal balloon provided by the anchor may be slipped over aninstrument, such as a trocar sheath, with which it is used. Initially,the shielding strip 16 would be left in place as the anchor is sopositioned. Once the balloon 10 is positioned as desired, its distal endwould be lifted and the shielding strip would be removed. Then theballoon 10 and the inflation tube 18 would be pressed into secureadhered relationship with the outside of the instrument, as shown inFIG. 42.

With the tenth embodiment anchor in place on a trocar sheath as shown inFIG. 42 and the balloons in deflated condition, the sheath is initiallypassed through a tissue layer and anchored with the distal balloon 10 insame manner as the first embodiment. Once so in place, the assembly 116is slid along the sheath into engagement with the outside of the tissue,as shown in FIG. 43, and inflated. The flexibility of the web 118facilitates such adjustment. Inflation of the assembly 116 serves tosecure the assembly against movement relative to the sheath and anchorthe sheath against distal movement.

CONCLUSION

From the foregoing description, it is believed apparent that the presentinvention enables the attainment of the objects initially set forthherein. In particular, it provides an anchor which may be readilyapplied to any surgical instrument without modification of theinstrument and which may be used with a minimum of trauma to thepatient. While all embodiments serve as effective anchors, the tenthembodiment is considered the preferred embodiment because of its ease ofmanufacture from two layers of film material and the secure anchor whichit provides against both proximal and distal movement. It should beunderstood, however, that the invention is not intended to be limited tothe specifics of the illustrated embodiments, but rather is defined bythe accompanying claims.

1. In combination with a trocar sheath, an improved anchoring system,comprising: a balloon system operatively securable to an outer surfaceof the trocar sheath, the balloon system having a low profile when in acontracted non-inflated condition closely adjacent the outer surface ofthe trocar sheath and an anchoring profile when in an expanded inflatedcondition extending laterally asymmetrically from the trocar sheath; theballoon system including: a self-contained balloon adapted to be securedalong an outside surface of the instrument such that when the balloonsystem is in the anchoring profile the balloon extends in a laterallyasymmetrical direction; a conduit for selectively inflating a balloonportion of the balloon system, the conduit including a portion extendingproximally along the outer surface of the trocar sheath; and securingstructure to selectively engage at least the self-contained balloon andthe outer surface of the trocar sheath upon inflation thereof to therebyanchor the trocar sheath against distal movement relative to a tissuethrough which the trocar sheath extends.
 2. In combination with a trocarsheath, an improved anchoring system, comprising: an elongate toroidalballoon operatively engageable with an outer surface of the trocarsheath, the balloon having a low profile when in a contractednon-inflated condition closely adjacent the outer surface of the trocarsheath and an anchoring profile when in an expanded inflated conditionextending radially outward from the trocar sheath; a conduit forselectively inflating the balloon, the conduit including a portionextending proximally along the outer surface of the trocar sheath; atleast one ring interposed between the balloon and the trocar sheath; andsecuring structure configured and adapted to allow a central portion ofthe balloon to press against the trocar sheath for anchoring of theballoon to the trocar sheath and to allow a distal end and a proximalend of the balloon to radially expand upon inflation of the balloon. 3.The anchoring system according to claim 2, wherein the securingstructure includes a ring disposed around the balloon between theproximal end and the distal end thereof, wherein the ring preventsexpansion of the balloon within a thickness thereof.
 4. The systemaccording to claim 2, wherein the securing structure includes aninelastic sleeve disposed over the balloon, wherein the inelastic sleeveis circumferentially secured to the balloon along a weld line, theinelastic sleeve including a perforated tear line extending from theweld line to a distal end thereof.
 5. In combination with a trocarsheath, an improved anchoring system, comprising: a self-containedasymmetrically expandable balloon system operatively coupled to an outersurface of the trocar sheath, the balloon system having a low profilewhen in a contracted non-inflated condition which is closely adjacentthe outer surface of the trocar sheath and an anchoring profile when inan expanded inflated condition extending laterally asymmetrically fromthe trocar sheath; and an inflatable toroidal balloon system operativelyengageable with the expandable balloon and the trocar sheath, theinflatable toroidal balloon system including: an elongate tubular bodyhaving a distal end and a proximal end, the tubular body defining aninflatable chamber, wherein the distal end and the proximal end aresecurable to one another to define an aperture of the toroidal balloonsystem; and a conduit in fluid engagement with one of the proximal anddistal ends of the tubular body for delivering a fluid to the inflatablechamber of the tubular body.
 6. In combination with a trocar sheath, animproved anchoring system, comprising: an elongate toroidal balloonoperatively engageable with an outer surface of the trocar sheath, theballoon having a low profile when in a contracted non-inflated conditionclosely adjacent the outer surface of the trocar sheath and an anchoringprofile when in an expanded inflated condition extending radiallyoutward from the trocar sheath; a conduit for selectively inflating theballoon, the conduit including a portion extending proximally along theouter surface of the trocar sheath; at least one ring interposed betweenthe balloon and the trocar sheath; and securing structure configured andadapted to allow a central portion of the balloon to press against thetrocar sheath for anchoring of the balloon to the trocar sheath and toallow a distal end and a proximal end of the balloon to radially expandupon inflation of the balloon, wherein the securing structure includes aring disposed around the balloon between the proximal end and the distalend thereof, wherein the ring prevents expansion of the balloon within athickness thereof.
 7. In combination with a trocar sheath, an improvedanchoring system, comprising: an elongate toroidal balloon operativelyengageable with an outer surface of the trocar sheath, the balloonhaving a low profile when in a contracted non-inflated condition closelyadjacent the outer surface of the trocar sheath and an anchoring profilewhen in an expanded inflated condition extending radially outward fromthe trocar sheath; a conduit for selectively inflating the balloon, theconduit including a portion extending proximally along the outer surfaceof the trocar sheath; and securing structure configured and adapted toallow a central portion of the balloon to press against the trocarsheath for anchoring of the balloon to the trocar sheath and to allow adistal end and a proximal end of the balloon to radially expand uponinflation of the balloon, wherein the securing structure includes aninelastic sleeve disposed over the balloon, wherein the inelastic sleeveis circumferentially secured to the balloon along a weld line, theinelastic sleeve including a perforated tear line extending from theweld line to a distal end thereof.
 8. In combination with a trocarsheath having a longitudinal axis and a circumference, an improvedanchoring system, comprising: a self-contained asymmetric balloon systemoperatively secured to an outer surface of the trocar sheath, theballoon system including a balloon portion having an elongate shapeextending along the longitudinal axis of the trocar sheath, the balloonportion having a low profile when in a contracted non-inflated conditionclosely adjacent the outer surface of the trocar sheath and an anchoringprofile when in an expanded inflated condition extending laterally awayfrom the longitudinal axis of the trocar sheath, the balloon portionextending on a portion of the circumference of the trocar sheath; theballoon system further including: a conduit for selectively inflatingthe balloon portion of the balloon system, the conduit including aportion extending proximally along the outer surface of the trocarsheath; and securing structure to selectively engage at least theself-contained balloon system and the outer surface of the trocar sheathupon inflation thereof to thereby anchor the trocar sheath againstdistal movement relative to a tissue through which the trocar sheathextends.
 9. In combination with a trocar sheath, an improved anchoringsystem, comparing: an elongate toroidal balloon operatively engageablewith an outer surface of the trocar sheath, the balloon having a lowprofile when in a contracted non-inflated condition closely adjacent theouter surface of the trocar sheath and an anchoring profile when in anexpanded inflated condition extending radially outward from the trocarsheath, the balloon having a length, wherein a portion of the length ofsaid balloon is in contact with an outer surface of said trocar sheath;a conduit for selectively inflating the balloon, the conduit including aportion extending proximally along the outer surface of the trocarsheath; at least one ring interposed between the balloon and the trocarsheath; and securing structure configured and adapted to allow a portionof the length of the balloon to press against the trocar sheath foranchoring of the balloon to the trocar sheath and to allow anotherportion of the balloon to radially expand upon inflation of the balloon.10. The anchoring system according to claim 9, wherein said portion ofthe length of the balloon is a middle portion.